YY 0592-2016: High intensity focused ultrasound therapy system

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Scope

This Standard specifies the terms and definitions, classification, requirements,
test methods, inspection rules as well as marks, packaging, transport and
storage for high intensity focused ultrasound therapy system.
This Standard applies to in-vitro focus high intensity focused ultrasound
(HIFU) therapy system (hereinafter referred to as HIFU therapy system). The
system is used for in-vitro high intensity focused ultrasound ablation therapy.

Basic Data

Standard ID	YY 0592-2016 (YY0592-2016)
Description (Translated English)	High intensity focused ultrasound therapy system
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C41
Classification of International Standard	11.040.50
Word Count Estimation	14,166
Date of Issue	1/26/2016
Date of Implementation	2018-01-01
Older Standard (superseded by this standard)	YY 0592-2005
Quoted Standard	GB/T 191; GB/T 3947-1996; GB 9706.1-2007; GB/T 14710; GB/T 19890-2005; YY/T 0162.1-2009; YY 0505
Regulation (derived from)	China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies)	State Food and Drug Administration
Summary	This International Standard specifies the terminology and definitions, classification, requirements, test methods, inspection rules and labeling, packaging, transport and storage of high intensity focused ultrasound (HIFU) treatment systems. This standard applies to high-intensity focused ultrasound (HIFU) treatment systems that are used for in vitro focused high-intensity focused ultrasound ablation.